Assistant Manager

2 weeks ago

Mumbai, Maharashtra, India 703 GlaxoSmithKline Pharmaceuticals Limited Full time

Basic Requirements:

Education: Graduate in Science / Pharmacy discipline Experience: Preferably 5 plus years' experience in Quality Assurance in Quality Management Systems, Documentation management and Pharmaceuticals formulations Special Knowledge: Good Knowledge of Documentation/ Regulatory requirements & Quality Management Systems. Effective verbal and communication skills, collaborative team member & team leader. Capable to work independently & efficiently. Business understanding: understanding the pharmaceutical industry.

Responsibilities:

Job Purpose:

External Supply Quality Strategy & Governance. Primary responsibilities for this role are as follows:

Deviations & CAPA management – To drive Deviation investigations with adequate & timely closures and CAPA management in ES India Rx and adherence to GSK QMS expectations. Change Control management – To drive implementation of changes through robust Change Management System in ES India Rx and adherence to GSK QMS expectations. Complaints management – To drive Compliant Management with adequate & timely closures in ES India Rx and adherence to GSK QMS expectations. Documentation management – To support cross functional team in defining document management and control culture. Management of document life cycle as per GSK QMS expectations in ES India Rx. To facilitate ESQ Tier calls, ES Quality weekly escalation calls and to provide support in Regional Quality Weekly Escalation by providing relevant data on weekly basis. To be Inspection Ready all the time for all the profiles/activities managed.

Key Responsibilities:

Deviation & CAPA management:


•To align the Deviation & CAPA management process as per GSK QMS requirements.

To drive Deviation process through adequate investigations & devising appropriate CAPAs. To track and monitor all the deviations of entire ES functions & CMOs for timely closure. To track the progress of all CAPAs generated at all ES functions for timely closure.


•To report Deviation & CAPA KPIs & any escalations to ES Quality

Council/ Governance Board forums periodically.


•To perform annual review of Deviation & CAPA management process to identify opportunities for improvement and process simplification.

Change Control management:

To align the Change Control management process as per GSK QMS requirements. To drive Change Control AL Panel review meeting to review and approve proposed change with effective impact assessment & action plan, in timely manner and support business with respect to change control process. To review Change control raised in VQMS for the adequacy in-line with applicable procedure. To support ES Team in trending & tracking of Change controls & it's actions and access to associated software. To co-ordinate for deployment of updates in Veeva QMS process for Change Control process in ES India Rx. To report Change control KPIs & any escalations to ES Quality Council/ Governance Board forums periodically. To perform annual reviews of Change Control Process to identify opportunities for improvement and process simplification.

Complaints management:

To align the Complaints management process as per GSK QMS requirements. To provide support to the investigation into the complaint carried out by the team in the manufacturing plant, to ensure that the complaint sample is provided to the manufacturing site on time and availability of any other material needed by the CMO for further investigation. To ensure required investigation is completed and corrective action is implemented on time; track the timely closure of complaints & to escalate any critical/major to appropriate stakeholders immediately. To provide support related to any additional information needed by the manufacturing site to carry out the investigation. To co-ordinate for deployment of Veeva QMS process for Complaints management process in ES India Rx. To report Complaints management KPIs & any escalations to ES Quality Council/ Governance Board forums periodically. To perform annual reviews of Complaints management process to identify opportunities for improvement and process simplification.

Documentation management:

To align the Documentation management process as per GSK QMS requirements. To manage document life cycle as per GSK global retention policy. To manage documents generated in ES (Hard and soft copies) are maintained in respective repositories in co-ordination with Departmental Record Coordinators. To issue document reference numbers to associates in ES as per request & maintain logs. To drive routine meetings with departmental record coordinators of ES, as per agenda. To maintain List of deputies to sign key documents, System Register etc. To Support ES team members for swift usage of Digital Signatures and co-ordinate with Global SMEs for trouble shooting if any. To support VQD users of ES India Rx from Documentation perspective. To perform annual reviews of Complaints management process to identify opportunities for improvement and process simplification.

Quality Escalation Call & Tier calls:

To facilitate ES Quality weekly escalation call and to provide support in Regional Quality escalation calls by providing relevant data on weekly basis. To conduct ES Quality Tier meetings as per GPS standards on daily basis. To ensure respective profile owners update their daily/weekly/monthly data on MS Teams. To provide a daily update on any overdue/ issues to ESQ QMS Lead and ESQ Head based on daily discussion.

Additional responsibilities:

To perform gap analysis between GSK documents QMS and ES Rx India LSOPs To prepare and revise of the SOPs as when required. To conduct MM/IBM audits as per the schedule. To ensure the all-time audit/inspection readiness for above mentioned job profile. To ensure all the KPI targets for relevant profiles are achieved and provide the relevant data/updates in this regard to ES Quality council and other forums. To identify and log the risks in RMS for any risks foreseen relevant to the assigned profile. To ensure VQMS actions & trainings in Mylearning/other tools are completed on time. To publish daily updates of relevant Power Bi dashboard. To perform any other task assigned by line manager.

*LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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